About this role
The Validation/Verification Coordinator coordinates the implementation of (new or updated) laboratory tests in compliance with applicable regulatory requirements and quality standards. Coordinates and oversees test validation and verification activities, associated documentation, and QA and CAP Director reviews to ensure timely report approval and support successful test implementation.
Key Accountabilities
Coordinate global validation or verification of laboratory tests.Align with operational teams and laboratories on required activities and documentation.Define and track validation/verification milestones with relevant stakeholders.Ensure compliance with global validation and verification standards.Complete, review, and approve all documentation, including final signed validation/verification reports. Education
Master's degree in Biochemistry/Life Sciences, or a bachelor’s degree with relevant experience.Experience
Minimum of 5-10 years of (medical) clinical laboratory experience, including at least 1-2 years of experience writing clinical laboratory validation/verification reports.Prior hands-on experience in method verification/validation is required.Working knowledge of EP Evaluator or similar statistical software for clinical laboratory validation/verification is required; familiarity with EP Evaluator specifically is preferred.
Abilities and/or Skills:
Honest, Dependable, Demonstrated Ability to Self-ManageDetail Oriented, Accurate, PreciseStrong Math SkillsStrong Organizational SkillsLogical Thinking, Good Reasoning AbilityStrong communication including verbal, writing, and presentation skillsDedication to quality, ethics, and customer serviceAbility to handle personal stressMental and emotional stability and maturityMotivation to excelShould be able to sit for long periods as per role requirementTeam Lead experience